Time - Man of the Year/Time_Man_of_the_Year_Compact_Publishing_3YX-Disc-1_Compact_Publishing_1993.iso/moy/012092/0120350.000

Text File | 1992-08-28 | 6KB | 125 lines

                                                                                MEDICINE, Page 40

A Strike Against Silicone


The FDA, citing new safety worries, clamps down on breast
implants

By ANDREW PURVIS -- With reporting by Elaine Lafferty/Los Angeles


    Since silicone breast implants were introduced 30 years
ago, millions of women have sworn by their results. For most,
the ample gel-filled sacs provided a welcome boost in
self-esteem. For 1 out of 4 recipients, they brought a return
to normality after the trauma of mastectomy. So when anecdotal
reports of health problems associated with the devices began
cropping up over the past several years, women were first
alarmed, then hugely relieved when surgeons asserted that the
stories were groundless. Now their confidence has once again
been shaken.

    Citing new evidence of health risks, Food and Drug
Administration chief David Kessler last week declared a
moratorium on silicone implants. He urged manufacturers to halt
marketing the devices and surgeons to stop inserting them in
women. In Spain and Australia health officials quickly followed
suit; Canada, Britain and France are reviewing their policies.
The decision stunned millions of women worldwide. "They are
angry, frustrated and concerned," said Dr. Norman Cole,
president of the American Society of Plastic and Reconstructive
Surgeons. "They want to know what is going on."

    Kessler's decision is based on evidence -- some of it
still sealed under court order -- that has come to light since
the FDA last reviewed safety information in November. At that
time, an advisory committee recommended that the implants be
left on the market. But studies released in the course of
recent legal proceedings against Dow Corning Wright, the largest
U.S. implant manufacturer, suggest that the company may have
known about safety problems for years and kept them under wraps.
Kessler said he has also received a number of case reports from
rheumatologists linking the device to autoimmune disorders. The
moratorium is in place until an expert advisory panel can review
the new information; a final verdict from the agency is due this
spring. Saline-filled implants, though less popular, are still
available.

    The latest information adds weight to several reports
about the dangers of silicone gel, a substance also sold as a
sealant and Silly Putty. If it stayed inside its envelope, the
gel would pose little danger. But doctors have found that over
the years it can leak into the surrounding breast tissue. In
some cases, especially in poorer-quality implants manufactured
between 1975 and 1985, the sacs rupture, spilling their contents
into the body. The immune system's attempt to wall off this
foreign chemical can cause inflammation and severe chest pain.
Worse, the silicone can migrate to the lungs, liver and lymph
nodes.

    Once there, some experts fear, the gel may trigger a
variety of autoimmune disorders as the body tries to protect
itself from the perceived invader. These include scleroderma,
which thickens and stiffens the skin and causes a buildup of
fibrous tissue in the lungs and other organs; lupus
erythematosus, which causes chronic joint pain and rashes; and
rheumatoid arthritis.

    The suspect gel has been linked to cancer in laboratory
rats, according to a 1988 report. One type of implant, which has
a polyurethane coating designed to prevent scar-tissue
formation, poses a special danger, and was withdrawn from the
market last April. The marshmallow-like foam coating has been
shown to break down into a chemical called TDA (2-toluene
diamine), which is known to cause cancer in animals.

    Frightening anecdotes abound. Kali Korn, 41, of Los
Angeles came down with scleroderma last year, a decade after she
had silicone implants inserted for cosmetic reasons. The skin
has so constricted around her fingers that she is virtually
unable to move them. Doctors removed the implants in March, and
she now says, "I feel much better. I wish I had realized 10
years ago that how I looked was fine."

    But despite similar accounts from hundreds of women,
scientists have yet to prove conclusively that implants are
responsible for their woes. Critics of last week's FDA ruling,
including many doctors, contend that the agency may have
needlessly raised women's fears before convincing evidence was
in. Cole feels that despite the court order, Kessler should have
released the new information to the medical community before
calling the moratorium. "We're getting hundreds of calls from
women who want to know what this new information is, what it
means," he said, adding that some women may avoid getting
suspicious breast lumps checked for fear that there are no
viable options for reconstruction.

    Women are clearly worried -- and angry. Sheila Swanson,
49, of Saratoga, Calif., had implants inserted three years ago
after a double mastectomy for breast cancer. Now she says, "I'm
frightened. At this point, emotionally, I don't know how I could
take another operation." Cindy Pearson, of the National Women's
Health Network in Washington, has been pushing the FDA to act
on this issue since 1983, and she is livid: "They've allowed
over half a million women to get into this horrible quandary
because they didn't order long-term studies earlier. If this
were heart valves, or anything used by both sexes, the FDA
wouldn't have gotten away with it."

    For now, women who have implants are being urged to see a
doctor only if they are experiencing suspicious symptoms.
Kessler recommends that women check their breasts regularly for
any sudden change in consistency or shape that might indicate
a rupture. The commissioner emphasizes that the slight risk of
removing the implants probably outweighs any potential danger
from leaving them in. That is some comfort. But for women who
have grown to cherish their new breasts as a part of themselves,
it doubtlessly is not enough.